The European Union has recently rolled out significant amendments to its Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) with the goal of addressing potential supply chain disruptions that could jeopardize the availability of medical devices and diagnostics. These
The Supreme Court's refusal to hear an emergency abortion case from Texas has highlighted the ongoing legal and political battle over abortion rights across the United States. Utilizing its discretionary power, the high court has left in place a lower court's ruling, which allows Texas to maintain
The rise in insulin prices has become a heated topic in healthcare discussions, drawing scrutiny towards the roles played by pharmacy benefit managers (PBMs) and pharmaceutical companies. Recently, Texas Attorney General Ken Paxton has taken a significant legal step by suing major PBMs and pharma
New regulations often elicit a mix of anticipation and apprehension, and the EU AI Act is no exception, especially in the life sciences and digital health sectors. As companies navigate the evolving regulatory landscape, understanding the implications of this legislative framework becomes essential
The cost of insulin has surged dramatically over the past decades, burdening patients who rely on this life-saving medication. Rising costs have drawn scrutiny from regulators, lawmakers, and consumers, leading to investigations into the pharmaceutical industry's pricing mechanisms. Among the
The call for legislative intervention to overturn the FDA's final rule on the regulation of laboratory-developed tests (LDTs) has intensified. The Association for Diagnostics and Laboratory Medicine (ADLM) has been at the forefront, urging lawmakers to take action against the FDA's new rule. This
